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Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Hospital Sao Domingos.
Recruitment status was:  Recruiting
Information provided by:
Hospital Sao Domingos Identifier:
First received: December 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
The aim of this prospective randomized study is to compare the safety and efficacy of two strategies for sedation of critically ill patients submitted to mechanical ventilation: continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The two groups will be compared as to the incidence of of delirium, evaluated with the Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or older intubated and mechanically ventilated for less than 48 hours prior to start of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146 patients (73 patients in each group)

Condition Intervention Phase
Mechanically Ventilated Patients Sedation Dexmedetomidine Midazolam Drug: Dexmedetomidine Drug: Midazolam Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Resource links provided by NLM:

Further study details as provided by Hospital Sao Domingos:

Primary Outcome Measures:
  • Incidence of delirium

Secondary Outcome Measures:

Estimated Enrollment: 146
Study Start Date: November 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DEXMEDETOMIDINE, SEDATION Drug: Dexmedetomidine
Active Comparator: Midazolam, sedation, Drug: Midazolam


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult mechanically ventilated, critically ill patients

Exclusion Criteria:

  • pregnancy or lactation, severe liver disease, hearth rate less than 50, hypotension despite volemic repletion and vasoactive drug
  Contacts and Locations
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Please refer to this study by its identifier: NCT01256866

Hospital Sao Domingos Recruiting
Sao Luis, Maranhao, Brazil, 65060-100
Contact: Jose R Azevedo, MD    55 98 32168110   
Principal Investigator: Jose R Azevedo, MD         
Sub-Investigator: Carla C Oliveira, RN         
Sponsors and Collaborators
Hospital Sao Domingos
  More Information

Responsible Party: Ethics Committee, Hospital Sao Domingos Identifier: NCT01256866     History of Changes
Other Study ID Numbers: hsd130947
Study First Received: December 8, 2010
Last Updated: December 8, 2010

Keywords provided by Hospital Sao Domingos:
Mechanical ventilation
Critically ill patients

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents processed this record on September 21, 2017